Action Observation Therapy in Hemiparetic CP: Impact on Balance & Lower Limb Function

NCT ID: NCT06942364

Last Updated: 2025-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-10

Study Completion Date

2024-12-10

Brief Summary

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Background:

Action Observation Therapy (AOT) leverages the mirror neuron system to enhance motor learning and is anticipated to improve upper extremity function in children with cerebral palsy. However, its effects on balance, lower extremity function, and gait performance in children with hemiparetic cerebral palsy remain underexplored. The planned study aims to evaluate whether the addition of AOT to conventional physiotherapy will positively influence balance, lower extremity function, and gait performance in this population.

Objective:

The study is designed to assess the efficacy of incorporating AOT as an adjunct to conventional physiotherapy in improving balance, lower extremity function, and gait performance in children with hemiparetic cerebral palsy.

Methods:

A patient cohort consisting of children with hemiparetic cerebral palsy (GMFCS levels I and II) is planned to be assembled.

It is expected that a total of 20 patients will be recruited and then randomly allocated into an experimental group and a control group.

The experimental group is scheduled to receive conventional physiotherapy in addition to AOT sessions, while the control group is planned to receive conventional physiotherapy only.

The intervention period is planned for 6 weeks, during which both groups will participate in 12 physiotherapy sessions.

Additionally, the experimental group is scheduled to undergo AOT sessions twice weekly, with each session lasting 30 minutes.

Outcome measures to be employed will include the Timed Up and Go (TUG) test, Pediatric Balance Scale, Five-Step Stair Climbing and Descending Test, and the 6-Minute Walk Test (6MWT).

This study is expected to systematically evaluate the potential benefits of adding AOT to standard physiotherapy regimens for enhancing balance, lower extremity function, and gait performance in children with hemiparetic cerebral palsy.

Detailed Description

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Conditions

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Hemiparetic Cerebral Palsy Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The discovery of the mirror neuron system's role in motor learning has led to the development of Action Observation Therapy (AOT). In AOT, patients observe a video of specific movements or watch an instructor perform actions, then attempt to imitate them. This rehabilitation strategy is designed to repair damaged neural networks and re-establish motor function in individuals with central nervous system lesions. While several studies have shown that AOT can improve upper extremity function and reaching performance in children with CP, there is limited evidence regarding its effects on lower extremity function. Notably, no studies from our country have investigated the impact of AOT on balance and lower extremity function in children with CP.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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experimental

Group Type EXPERIMENTAL

Action Observation Therapy

Intervention Type OTHER

The AOT video comprised four specific tasks designed to improve lower extremity function, balance, and gait (Figure 1):

1. Sitting Balance: Movements to enhance balance while seated (Figure 2).
2. Sit-to-Stand Transition: Exercises to facilitate the transition from sitting to standing.
3. Walking and Balance: Gait and balance training on a parallel bar or flat surface.
4. Single-Leg Balance: Activities focused on improving balance on one leg. For each task, children observed the movement for 1 minute, then practiced the action for 5 minutes. A 1-minute rest period was allowed between tasks, with a total AOT session lasting 30 minutes. All sessions were conducted by the same physiotherapist.

conventional physiotherapy

Intervention Type OTHER

Conventional physiotherapy is a widely used therapeutic approach that focuses on improving physical function, mobility, and overall quality of life through evidence-based techniques. It typically includes exercises for strength, flexibility, balance, and coordination, along with manual therapy, postural training, and education about movement and body mechanics. This traditional method is commonly applied in the rehabilitation of patients with neurological, orthopedic, and musculoskeletal conditions. In pediatric populations, such as children with cerebral palsy, conventional physiotherapy plays a vital role in promoting motor development, enhancing functional independence, and preventing secondary complications.

control

Group Type ACTIVE_COMPARATOR

conventional physiotherapy

Intervention Type OTHER

Conventional physiotherapy is a widely used therapeutic approach that focuses on improving physical function, mobility, and overall quality of life through evidence-based techniques. It typically includes exercises for strength, flexibility, balance, and coordination, along with manual therapy, postural training, and education about movement and body mechanics. This traditional method is commonly applied in the rehabilitation of patients with neurological, orthopedic, and musculoskeletal conditions. In pediatric populations, such as children with cerebral palsy, conventional physiotherapy plays a vital role in promoting motor development, enhancing functional independence, and preventing secondary complications.

Interventions

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Action Observation Therapy

The AOT video comprised four specific tasks designed to improve lower extremity function, balance, and gait (Figure 1):

1. Sitting Balance: Movements to enhance balance while seated (Figure 2).
2. Sit-to-Stand Transition: Exercises to facilitate the transition from sitting to standing.
3. Walking and Balance: Gait and balance training on a parallel bar or flat surface.
4. Single-Leg Balance: Activities focused on improving balance on one leg. For each task, children observed the movement for 1 minute, then practiced the action for 5 minutes. A 1-minute rest period was allowed between tasks, with a total AOT session lasting 30 minutes. All sessions were conducted by the same physiotherapist.

Intervention Type OTHER

conventional physiotherapy

Conventional physiotherapy is a widely used therapeutic approach that focuses on improving physical function, mobility, and overall quality of life through evidence-based techniques. It typically includes exercises for strength, flexibility, balance, and coordination, along with manual therapy, postural training, and education about movement and body mechanics. This traditional method is commonly applied in the rehabilitation of patients with neurological, orthopedic, and musculoskeletal conditions. In pediatric populations, such as children with cerebral palsy, conventional physiotherapy plays a vital role in promoting motor development, enhancing functional independence, and preventing secondary complications.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Diagnosed hemiparetic type of cerebral palsy

Exclusion Criteria

* Any other types of cerebral palsy
Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fatih Tekin

OTHER

Sponsor Role lead

Responsible Party

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Fatih Tekin

Assist. Prof.

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Pamukkale University Faculty of Physiotherapy and Rehabilitation

Denizli, Kınıklı, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Action Observation Therapy

Identifier Type: -

Identifier Source: org_study_id

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